ENCORE STANDING AID 의 리콜

Health Canada (via FOI)에 따르면, 해당 리콜 는 Canada 에서 ARJO CANADA INC. 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    55894
  • 사례 위험등급
    I
  • 사례 시작날짜
    2012-05-24
  • 사례 국가
  • 사례 출처
    HC
  • 비고 / 경고
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • 데이터 추가 비고
  • 원인
    Arjohuntleigh has been made aware of a serious incident. during exercise a standing and raising aid was used to support a patient to stand. the knee pad had been removed. however the support bracket holding the proactive knee pad support had not been removed as described in the instructions for use manual. this results in a vertical square section end of the metal support bracket becoming exposed and patients may fall onto the metal bracket causing severe trauma. this accident could have been avoided if the support bracket assembly had been removed with the proactive knee pad support. arjohuntleigh would like to remind users that the entire knee pad and support bracket assembly must be removed when required to do so for exercise.

Device

  • 모델명 / 제조번호(시리얼번호)
    Model Catalog: KKB5040-21US (Lot serial: >100 numbers contact mfg); Model Catalog: KKB5042-21US (Lot serial: >100 numbers contact mfg); Model Catalog: KKB5022-21US (Lot serial: >100 numbers contact mfg); Model Catalog: KKB5020-21US (Lot serial: >100 numbers contact mfg); Model Catalog: HEP1001-US (Lot serial: >100 numbers contact mfg); Model Catalog: HEP0001-US (Lot serial: >100 numbers contact mfg); Model Catalog: KKB5060-23US (Lot serial: >100 numbers contact mfg); Model Catalog: KKB5060-21US (Lot serial: >100 numbers contact mfg); Model Catalog: KKB5080-21US (Lot serial: >100 numbers contact mfg); Model Catalog: KKB5080-23US (Lot serial: >100 numbers contact mfg)
  • 의료기기 분류등급
  • 제품 설명
    ENCORE STANDING AID
  • Manufacturer

Manufacturer

  • 제조사 주소
    MISSISSAUGA
  • 제조사 모회사 (2017)
  • Source
    HC